The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set is intended for use during hernodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.

Device Description

The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set that we intend to market includes the following three components: a Nipro® Arterial and Venous Blood Tubing Set for Hemodialysis; a Nipro® Disposable Solution Set ; and, a transducer/ protector. These devices are packaged together for convenient use during hemodialysis procedures. The Arterial and Venous Blood Tubing Sets that we intend to include within the kits include various models of blood tubing sets are available for application with different dialysis machines. A series of 27 arterial line models (A001 - A021, A026, A029 -A032, and A035) and a series of 14 venous line models (V600 - V607, V609 - V613, and V616) have been described. The Disposable Solution Infusion Set that we intend to include in the kit will be one of the 4 types of designs: NNC-3L, NNC-3CL. NNC-3C. and NNC-3CS. A transducer/protector is also included in the kit. The materials used for the components of the blood tubing sets include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polyethylene high density (PEHD), and polycarbonate (PC). The materials used for the disposable solution infusion set include polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and acrylonitrate butadiene styrene (ABS). The transducer/protector component of this kit is fabricated from either rigid PVC and a 0.2 micron Gore membrane (PTFE and polypropylene) or rigid PVC and PTFE and polyester.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set) seeking substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as an existing, legally marketed device. It does not typically involve the kind of performance studies with explicit acceptance criteria related to AI output, ground truth establishment, or human reader performance as would be seen for AI/ML-based medical devices.

Therefore, many of the requested categories are not applicable to this document. The study described is primarily focused on biocompatibility and comparison of technical characteristics to a predicate device.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility:
Cytotoxicity	Conforms to appropriate specifications
Mutagenicity	Conforms to appropriate specifications
Hemolysis	Conforms to appropriate specifications
Acute Systemic Toxicity	Conforms to appropriate specifications
Intracutaneous Reactivity	Conforms to appropriate specifications
Implantation Tests	Conforms to appropriate specifications
Pyrogenicity	Conforms to appropriate specifications
Sensitization	Conforms to appropriate specifications
Material Equivalence:
Transducer/protector materials identical to blood tubing set components	Yes, "The transducer/protector is composed of materials identical to those contained in blood tubing set components and similar to marketed components."
Substantial Equivalence to Predicate Device:
Configuration similar to legally marketed devices	Yes, "The configuration of the subject device kit is similar to legally marketed devices from Medisystems Corporation."
Labeling similar to predicate device	Yes, "Labeling for the competitor's devices is similar to the subject device."
Intended use similar to predicate device	Yes, "the intended use for the competitors' products is similar to that of the subject device."
Labeled as sterile	Yes, "All of the devices are labeled as sterile"
Labeled for single use only	Yes, "and for single use only."
Restricted to sale by or on the order of a physician	Yes, "The devices are restricted to sale by or on the order of a physician."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for biocompatibility tests. For the comparison to the predicate device, it appears to be a qualitative comparison of device characteristics rather than a quantitative test set with a specific sample size.
Data Provenance: Not specified, but generally, biocompatibility testing is performed in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This type of information is not relevant to a 510(k) submission primarily focused on material safety and equivalence to a predicate device. Biocompatibility results are typically based on laboratory assay outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. This concept is relevant for expert review of medical images or other complex data where ground truth is ambiguous. It does not apply to the described biocompatibility testing or comparison of device characteristics.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is a physical medical device, not an AI/ML-based diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Biocompatibility ground truth: Standards for
- Cytotoxicity
- Mutagenicity
- Hemolysis
- Acute Systemic Toxicity
- Intracutaneous Reactivity
- Implantation toxicity (e.g., irritation, inflammation)
- Pyrogenicity
- Sensitization
Equivalence ground truth: Characteristics of the legally marketed predicate device (Medisystems Corporation ReadySet™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors).

8. The sample size for the training set:

Not Applicable. This is a physical medical device, not an AI/ML system.

9. How the ground truth for the training set was established:

Not Applicable. This is a physical medical device, not an AI/ML system.

Summary

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K972206 PAGE 1 OF 3

Image /page/0/Picture/2 description: The image shows the logo for Nipro. The logo consists of a stylized infinity symbol to the left of the word "NIPRO" in bold, sans-serif font. The infinity symbol is made up of two interlocking loops, and the word "NIPRO" is in all caps.

CORPORATION 0877 N.W. 33rd Street Miami. Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454

SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set

$807.92 (a)(1)

Submitter:

Nipro Medical Corporation

Contact Person:

Luis Candelario General Manager

September 24, 1997

Date of Summary Preparation:

$807.92 (a)(2)

Trade Name:	Nipro® Blood Tubing Set for HemodialysiswithTransducer Protectors and Priming Set
Common Name:	Blood tubing set with priming set and transducer/protectors
Classification Name:	Blood access device and accessories (21 CFR876.5540)

$807.92 (a)(3)

Legally Marketed Substantially Equivalent Devices:

Medisystems Corporation ReadySet™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors

8807.92 (a)(1)

Description of Device:

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page 2 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer/Protectors and Priming Set

The Arterial and Venous Blood Tubing Sets that we intend to include within the kits include various models of blood tubing sets are available for application with different dialysis machines. A series of 27 arterial line models (A001 - A021, A026, A029 -A032, and A035) and a series of 14 venous line models (V600 - V607, V609 - V613, and V616) have been described. The Disposable Solution Infusion Set that we intend to include in the kit will be one of the 4 types of designs: NNC-3L, NNC-3CL. NNC-3C. and NNC-3CS. A transducer/protector is also included in the kit.

The materials used for the components of the blood tubing sets include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polyethylene high density (PEHD), and polycarbonate (PC). The materials used for the disposable solution infusion set include polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and acrylonitrate butadiene styrene (ABS). The transducer/protector component of this kit is fabricated from either rigid PVC and a 0.2 micron Gore membrane (PTFE and polypropylene) or rigid PVC and PTFE and polyester.

8807.92 (a)(5)

The Blood Tubing Set for Hemodialysis with Transducer Protectors Intended Use: and Priming Set is intended for use during hemodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.

8807.92 (a)(6)

Comparison of Technical Characteristics:

The configuration of the subject device kit is similar to legally marketed devices from Medisystems Corporation. Labeling for the competitor's devices is similar to the subject device. According to the device names on the labeling, the intended use for the competitors' products is similar to that of the subject device. They are used for hemodialysis. All of the devices are labeled as sterile and for single use only. The devices are restricted to sale by or on the order of a physician. The blood tubing sets and disposable solution infusion sets are already cleared for market individually and demonstrated to be biocompatible according to necessary testing and prior clinical use. The transducer/protector is fabricated from identical materials to those contained in certain blood tubing set components. Transducer/protectors have also undergone biocompatibility testing and are similar to marketed components.

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page 3 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set

The following biocompatibility tests were performed on the components of $807.92 (b)(1) the subject device kit: cytotoxicity, mutagenicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, implantation tests, pyrogenicity, and sensitization. Results indicate that the blood tubing sets conform to the appropriate specifications.
The Nipro Disposable Blood Tubing Set for Hemodialysis and Disposable $807.92 (b)(3) Solution Infusion Set have already been determined to be substantially equivalent to legally marketed devices. The transducer/protector is composed of materials identical to those contained in blood tubing set components and similar to marketed components.

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Mr. Luis Candelario General Manager Nipro Medical Corporation 10877 N.W. 33rd Street Miami, Florida 33172

Re: K972206 Nipro® Blood Tubing Set with Transducer Protectors and Priming Set for Hemodialysis Dated: August 27, 1997 Received: September 4, 1997 Regulatory Class: II

21 CFR §876.5820/Product code: 78 KOC

Dear Mr. Candelario:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions; or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general

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Page 2 - Mr. Luis Candelario

information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Robert R. Setting/

Lillian W. Ph.D.

$\xi$

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K972206

Device Name: Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set

Indications for Use: The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set is intended for use during hernodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109)

Over-The-Counter Use

Robert L. Satterly/

(Division Sign-Off) -2-Division of Reproductive, Abdominal, ENT, and Radiological Devices (972206 510(k) Number_

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.